Romania proposes temporary capping of prices for coronavirus medicines

On 31 March 2020, the Romanian Senate adopted a draft law that caps the prices of over-the-counter (OTC) medicines included in the protocol for the treatment of the infection associated with the SARS-Cov-2 virus (coronavirus), which was approved by Order No 487/2020 of the Romanian Ministry of Health at the beginning of last week (see more about this Order here).

These medicines are: the experimental antiviral compound Remdesivir, the malaria medication hydroxychloroquine, the HIV drugs lopinavir and ritonavir, and the immunosuppressive drug Tocilizumab. Note, the medical devices used for protection, sanitary materials and food supplements that are related to the state of emergency (e.g. medical masks, hazmat suits) will also be subject to this measure.

The proposed piece of legislation provides that the maximum mark-up on the entire distribution and retail chain will be 10% over the production-import price. This measure will apply for the entire period of the state of emergency and for a maximum 90 days after the state of emergency ceases.

Failure to comply with this price limitation will result in fines starting at RON 5,000,000 (EUR 1,050,000), but not exceeding 4% of the company’s turnover.

A vote on the proposed legislative change adopted by the Romanian Senate was scheduled to take place in the Romanian Chamber of Deputies today, 3 April 2020. According to the Romanian parliament's official website, this draft law was not included in the agenda. We will monitor the status of the proposal and provide further details when available.

For more information on this draft law and Romania's pharma industry, contact your regular CMS advisor or local CMS experts Valentina Parvu and Cosmin Cretu.